MRI in Primary Prostate cancer after Exposure to Dutasteride (MAPPED)

• Research type

  Research Study

• Full title

  Single site, phase II, double blind, randomised, placebo controlled study of the effect of dutasteride (Avodart)0.5 mg on the volume and characteristics of prostate cancer, as assessed by multifunctional magnetic resonance imaging (MRI) in a low risk prostate cancer population

• IRAS ID

  11654

• Contact name

  Mark Emberton

• Sponsor organisation

  University College London

• Eudract number

  2009-102405-18

• ISRCTN Number

  not issued

• Research summary

  Many men diagnosed with prostate cancer do not require immediate treatment, and are suitable for active monitoring of the cancer, using blood tests, biopsies and MRI scans.It is known that the volume of prostate cancer is an important predictor of prostate cancer progression. MRI can be used to measure prostate cancer volume, and, therefore, the effect on prostate cancer volume of different treatments. Dutasteride, a 5 alpha reductase inhibitor currently licensed for benign prostatic hyperplasia, has been shown to cause a reduction in overall prostate volume by a mean of 25%. It has been shown to reduce the incidence of prostate cancer on biopsy, in men with a raised PSA, in comparison to placebo. We postulate that dutasteride may be able to reduce the volume of prostate cancer, as measured by MRI, and so lead to an improved outcome for men with prostate cancer.Men who have been diagnosed with prostate cancer on biopsy, and who are not planning to undertake an active treatment (eg surgery or radiotherapy) would be eligible for the study. The study will be undertaken at University College Hospitals Trust, London. Men who agree to take part will first have a multi sequence MRI scan of the prostate,using a 3 Tesla MR scanner, which is more powerful than the 1.5 Tesla MRI scanner usually used in the NHS. If the MRI scan shows a volume of prostate cancer which can be measured (>0.2cc) then the patient would proceed to the randomisation part of the study. Men would be randomised, with a 1:1 ratio, between 0.5mg dutasteride and a placebo, for a six month period. The MRI scan would be repeated at 3 and 6 months, in order to look for any change in the volume, or other characteristics of the prostate cancer.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0707/84

• Date of REC Opinion

  8 Jan 2010

• REC opinion

  Further Information Favourable Opinion